Accessory Joint and Neural Mobilizations in Shoulder After Breast Cancer Surgery. Randomized Clinical Trial.
Primary Purpose
Breast Cancer
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Accessory joint mobilization
Nerve mobilization
Sponsored by

About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring accessory mobilization, nerve mobilization.
Eligibility Criteria
Inclusion Criteria:
- unilateral breast cancer diagnosis
- breast cancer with axillary lymph node dissection
- be willing to sign the informed consent form
Exclusion Criteria:
- bilateral breast cancer diagnosis
- loco-regional recurrence
- systemic disease
- had not undergone the axillary lymph node dissection approach
- to present any contraindication for Physical Therapy.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Accessory joint mobilization
Nerve mobilization
Arm Description
Humeral head slides, anterior, posterior and caudal slides.
neural tissue longitudinal slide using the median neurodynamic test 1 (Butler).
Outcomes
Primary Outcome Measures
Shoulder Range of motion
Shoulder movements measured: flexion, extension, abduction, external e internal rotation.
Measure instrument: inclinometer. Unit of measure: degrees. Number of participants: 18.
Secondary Outcome Measures
Pain
Measure instrument: Visual Analogue Scale to measure the grade of pain: scale from 0 (no pain) to 10 (unbearable pain). Patients choose where is located their pain throughout this scale.
Unit of measure: from 0 to 10 points. Number of participants: 18.
Upper limb functionality
Measured items: daily life activities related to the upper limb such as to comb, to get washed, to button the bra, to mop the floor, to clean windows, to hang up, to make the bed, to carry the shopping cart, to put on the pullover, to take off the pullover, leisure.
Measure instrument: the Wingate's Daily Life Activities Table to measure the daily life activities difficulty. Patients give a score of how difficult is each daily life activity. Score from 0 (no difficulty) to 3 (disability).
Unit of measure: from 0 to 3 points. Number of participants: 18.
Full Information
NCT ID
NCT02366793
First Posted
January 17, 2015
Last Updated
September 15, 2015
Sponsor
University of Alcala
1. Study Identification
Unique Protocol Identification Number
NCT02366793
Brief Title
Accessory Joint and Neural Mobilizations in Shoulder After Breast Cancer Surgery. Randomized Clinical Trial.
Official Title
Accessory Joint and Neural Mobilizations in Shoulder Range of Motion Restriction After Breast Cancer Surgery. A Pilot Randomized Clinical Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alcala
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The potential consequences after breast cancer surgery are joint pain and sensitive disorders, the main sign of which is alterations in shoulder mobility. Global kinesitherapy has been shown to be effective at increasing shoulder range of motion restriction. However, literature does not consider specific manual therapy techniques, which means peripheral nerves and articular capsule have not been taken into account. These two tissues are potentially damaged structures during surgery and they are main responsible for shoulder range of motion restriction The main objective of this study is to pilot the effectiveness of accessory joint and nerve mobilization techniques in order to get an overview of the articular capsule and nerve dysfunctions involvement in shoulder motion restriction.
Detailed Description
Background: The potential consequences after breast cancer surgery are joint pain and sensitive disorders, the main sign of which is alterations in shoulder mobility. Design: Prospective randomized and double-blind pilot trial. Objective: To pilot the effectiveness of accessory joint and nerve mobilization techniques in order to get an overview of the joint capsule and nerve involvement in shoulder motion restriction. Participants: 18 women who were undergoing unilateral breast cancer surgery and axillary lymph node dissection. Setting: Women´s Health Research Group at Physical Therapy Department of University of Alcala, Madrid, Spain. Intervention: accessory joint mobilization versus neural mobilization. Follow-up: Six-month follow-up. Key outcomes: Range of motion, sensitive disorder, pain and upper limb functionality.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
accessory mobilization, nerve mobilization.
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Accessory joint mobilization
Arm Type
Experimental
Arm Description
Humeral head slides, anterior, posterior and caudal slides.
Arm Title
Nerve mobilization
Arm Type
Experimental
Arm Description
neural tissue longitudinal slide using the median neurodynamic test 1 (Butler).
Intervention Type
Other
Intervention Name(s)
Accessory joint mobilization
Intervention Description
Three kinds of humeral head slides: anterior, posterior and caudal slides. Subjects remained in supine position during the whole treatment. The techniques were applied in a rhythmical way, with 2 seconds of slide/traction and then a 2-second break. Each technique was carried out for 2 minutes.
Intervention Type
Other
Intervention Name(s)
Nerve mobilization
Intervention Description
Neural tissue longitudinal slide using the median neurodynamic test 1 (MNT1) that was described by Butler. The proximal parameters (scapular depression, abduction and humeral external rotation) were introduced with maximum neural tension. On the other hand, the distal parameters (supination, elbow extension, wrist and fingers extension) received the remaining tension that the neural tissue allowed. The parameters were introduced sequentially in the order exposed
Primary Outcome Measure Information:
Title
Shoulder Range of motion
Description
Shoulder movements measured: flexion, extension, abduction, external e internal rotation.
Measure instrument: inclinometer. Unit of measure: degrees. Number of participants: 18.
Time Frame
15 min
Secondary Outcome Measure Information:
Title
Pain
Description
Measure instrument: Visual Analogue Scale to measure the grade of pain: scale from 0 (no pain) to 10 (unbearable pain). Patients choose where is located their pain throughout this scale.
Unit of measure: from 0 to 10 points. Number of participants: 18.
Time Frame
5 min
Title
Upper limb functionality
Description
Measured items: daily life activities related to the upper limb such as to comb, to get washed, to button the bra, to mop the floor, to clean windows, to hang up, to make the bed, to carry the shopping cart, to put on the pullover, to take off the pullover, leisure.
Measure instrument: the Wingate's Daily Life Activities Table to measure the daily life activities difficulty. Patients give a score of how difficult is each daily life activity. Score from 0 (no difficulty) to 3 (disability).
Unit of measure: from 0 to 3 points. Number of participants: 18.
Time Frame
10 min
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
unilateral breast cancer diagnosis
breast cancer with axillary lymph node dissection
be willing to sign the informed consent form
Exclusion Criteria:
bilateral breast cancer diagnosis
loco-regional recurrence
systemic disease
had not undergone the axillary lymph node dissection approach
to present any contraindication for Physical Therapy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MARÍA TORRES-LACOMBA, DOCTOR
Organizational Affiliation
SUPERVISOR
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Accessory Joint and Neural Mobilizations in Shoulder After Breast Cancer Surgery. Randomized Clinical Trial.
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